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Trial registered on ANZCTR


Registration number
ACTRN12609000897268
Ethics application status
Approved
Date submitted
14/10/2009
Date registered
15/10/2009
Date last updated
9/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
To investigate the acute effect of chilli intake on plasma glucose, insulin and blood vessel function in type-2 diabetics.
Scientific title
An ordered study to determine postprandial effects of chilli consumption on plasma glucose, insulin and vascular function in type-2 diabetics.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperglycemia and hyperinsulinemia associated with type-2 diabetes. 252001 0
Condition category
Condition code
Metabolic and Endocrine 252193 252193 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An ordered study design comparing the effects of a standard bland meal and a standard meal with 30g of chilli paste. The standard meal wil consist of a bread roll, beef or soy patty (according to the subject's preference) and glucose drink (approximately 100g of Glucaid, which contains 75g of glucose per 300ml).
Participants are required to consume both of the meals, starting with the standard bland meal and then the chilli paste containing meal, with a one week period between the visits.
Intervention code [1] 241411 0
Other interventions
Comparator / control treatment
Chilli-free bland meal
Control group
Active

Outcomes
Primary outcome [1] 253072 0
Glucose tolerance - meal challenge test. Glucose will be measured by blood analysis.
Timepoint [1] 253072 0
Samples will be taken after an overnight fast (10 to 12 hours), and 20, 40, 60, 90, 120, 150 and 180 minutes postprandially.
Primary outcome [2] 253073 0
Insulin measured by blood analysis.
Timepoint [2] 253073 0
Samples will be taken after an overnight fast (10 to 12 hours), and 20, 40, 60, 90, 120, 150 and 180 minutes postprandially.
Secondary outcome [1] 257909 0
Platelet aggregation measured using adenosine diphosphate (ADP) induced platelet aggregation.
Timepoint [1] 257909 0
Samples were taken after a overnight fast (10 to 12 hours), one hour, two hours and three hours postprandially.
Secondary outcome [2] 257910 0
C-peptide measured by blood analysis.
Timepoint [2] 257910 0
Samples will be taken after an overnight fast (10 to 12 hours), and 20, 40, 60, 90, 120, 150 and 180 minutes postprandially.
Secondary outcome [3] 257911 0
Triglycerides measured by blood analysis.
Timepoint [3] 257911 0
Samples will be taken after an overnight fast (10 to 12 hours), and 20, 40, 60, 90, 120, 150 and 180 minutes postprandially.
Secondary outcome [4] 257912 0
Ghrelin measured by blood analysis.
Timepoint [4] 257912 0
Samples will be taken after an overnight fast (10 to 12 hours), and 20, 40, 60, 90, 120, 150 and 180 minutes postprandially.
Secondary outcome [5] 257913 0
Xylose measured by blood analysis.
Timepoint [5] 257913 0
Samples will be taken after an overnight fast (10 to 12 hours), and 20, 40, 60, 90, 120, 150 and 180 minutes postprandially.
Secondary outcome [6] 257914 0
Brachial blood pressure measured using a semiautomated electronic blood pressure monitor.
Timepoint [6] 257914 0
Samples will be taken after an overnight fast (10 to 12 hours), and 20, 40, 60, 90, 120, 150 and 180 minutes postprandially.
Secondary outcome [7] 257915 0
Central blood pressure measure using pulse wave analysis technique
Timepoint [7] 257915 0
Samples will be taken after an overnight fast (10 to 12 hours), and 20, 40, 60, 90, 120, 150 and 180 minutes postprandially.

Eligibility
Key inclusion criteria
Males and females, aged between 35 and 75 years, diagnosed with type-2 diabetes.
Minimum age
35 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those taking antihypertensive, hypoglycaemic and/or insulin sensitising medication.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subject screening is performed to ensure they meet the inclusion/exclusion criteria.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As this is an ordered study design there is not randomisation of meals.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Ordered study design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243873 0
Charities/Societies/Foundations
Name [1] 243873 0
Clifford Craig Medical Research Trust
Country [1] 243873 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
1 Newnham Drive, Newnham, TAS 7250
Country
Australia
Secondary sponsor category [1] 251221 0
None
Name [1] 251221 0
Address [1] 251221 0
Country [1] 251221 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243995 0
Tasmanian Human Research Ethics Committee (Tasmania) Network
Ethics committee address [1] 243995 0
Ethics committee country [1] 243995 0
Australia
Date submitted for ethics approval [1] 243995 0
01/01/2007
Approval date [1] 243995 0
14/06/2007
Ethics approval number [1] 243995 0
H9417

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30386 0
Address 30386 0
Country 30386 0
Phone 30386 0
Fax 30386 0
Email 30386 0
Contact person for public queries
Name 13633 0
Dr. Kiran Ahuja
Address 13633 0
School of Human Life Sciences
University of Tasmania
Locked Bag 1320
Launceston TAS 7250
Country 13633 0
Australia
Phone 13633 0
+61 3 6324 5478
Fax 13633 0
Email 13633 0
[email protected]
Contact person for scientific queries
Name 4561 0
Dr. Kiran Ahuja
Address 4561 0
School of Human Life Sciences
University of Tasmania
Locked Bag 1320
Launceston TAS 7250
Country 4561 0
Australia
Phone 4561 0
+61 3 6324 5478
Fax 4561 0
Email 4561 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.